FDA guidance on generic drug development during COVID-19

Home/Guidelines | Posted 21/05/2021 post-comment0 Post your comment

The US Food and Drug Administration (FDA) has released guidance on generic drug development and the submission of abbreviated new drug applications (ANDAs) during COVID-19, which explains how manufacturers can overcome issues caused by the pandemic.

Coronavirus wiki V20E08

The COVID-19 pandemic has impacted drug development in a number of ways, for example, by disrupting supply of ingredients and delaying inspections of manufacturing plants. In 2020, FDA released a comprehensive statement regarding the impact of the pandemic on the medical supply chain [1].

In April 2021, the Administration released new guidance for industry on the development of generic drugs during the COVID-19 pandemic, as a series of questions and answers. The document is a compilation of questions received from applicants during COVID-19 relating to:

Generic drug development

  • Expiration of test product batch due to study interruptions
  • Expiration of reference product batch due to development programme interruptions
  • Use of non-US approved product as reference standards
  • Efforts to maintain social distancing at study sites/laboratories
  • Submission of study data with a truncated sampling scheme
  • Alternative study proposals, such as interim analysis or remote study design

ANDA submission and assessment

  • Expedited ANDAs for generic drug products against COVID-19
  • Receipt evaluation for ANDAs for generic drug products against COVID-19
  • ANDAs without the recommended batch stability data
  • ANDAs with incomplete bioequivalence study data
  • ANDAs including sites that cannot be inspected due to travel restrictions

Marketing and exclusivity

  • Marketing of tentatively approved generics that could be used against COVID-19
  • The impact of inspection delays on eligibility for 180-day generic exclusivity

FDA says it recognizes that the COVID-19 pandemic has impacted the development of generic drug products, by interruptions to bioequivalence studies for example. The guidance clarifies what to do in these situations, where test or reference product may have expired. It also explains that the Administration will expedite the assessment of products that could be used to address the COVID-19 pandemic, although ANDAs will generally still require a full complement of batch stability data and completed bioequivalence study data. The Administration will not however reject an application on the basis that it includes sites that cannot currently be inspected and will consider any inspection delays in 180-day exclusivity decisions.

In total the guidance includes 15 Q & As, which can be read in full on the FDA website.

Related articles
Key considerations for payers, employers and patients in the US biosimilars market

UnitedHealthcare to preferentially cover Amgen’s anticancer biosimilars

Biosimilars of pegfilgrastim


To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America.

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.



Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica.

Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa. 

1. GaBI Online - Generics and Biosimilars Initiative. FDA’s response to coronavirus [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 21]. Available from: www.gabionline.net/Pharma-News/FDA-s-response-to-coronavirus

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2021 Pro Pharma Communications International. All Rights Reserved.

Source: US FDA

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010